Pharmaceutical Validation Specialist - Montréal
Neoka – Carrière – Offres d’emplois – Offre
Responsibilities
What You Will Accomplish
Based in our Montreal office, located in the heart of the city, you will join a collaborative and agile team of about ten professionals. You will leverage your project management skills and pharmaceutical industry expertise to support our clients in executing high-value-added projects. Through your assignments, you will integrate into major pharmaceutical manufacturing companies, providing validation expertise and technical guidance throughout project execution.
Validation Specialist:
- Participate in pre-validation activities to define validation requirements and schedules, including the preparation and approval of pre-validation documents (VP, URS, FRS, DS, FAT, SAT)
- Participate in factory acceptance tests (FAT) and site acceptance tests (SAT) during equipment installation
- Plan the necessary resources for validation study execution
- Draft validation protocols and corresponding reports
- Execute validation-related activities
- Write deviation reports when applicable, assess the impact on validation and product quality, investigate root causes, contribute to corrective action plans, ensure follow-up, and perform re-testing if necessary
- Provide final recommendations, record data, and manage the approval flow of validation documentation
- Plan, monitor, and ensure the execution of all activities related to validation and equipment, system, and process requalification studies
- Coordinate problem-solving activities related to validation issues
- Provide guidance and recommendations in decision-making related to the Quality System
Operations
Contract : Permanent
Full time (40h)
Montréal, Canada
Project management
Ideal Candidate
What We Are Looking For
Do you see yourself in this description? Here are the skills and qualities we value at NEOKA.
Education and Certifications :
- Bachelor’s degree in mechanical, Chemical, Process, Biotechnological, or Microbiological Engineering, or any other relevant engineering discipline
- Experience:
- Minimum 3 to 4 years of relevant experience in the pharmaceutical, food, healthcare, or other regulated industries; proven experience in consulting engineering is also highly valued
- Knowledge and Skills:
- Proficiency in French and English (spoken and written)
- Strong knowledge of GMP (Good Manufacturing Practices)
- Proficiency in Microsoft Office Suite
- Preferred Qualifications (not required):
- Member of the OIQ (Ordre des ingénieurs du Québec) – Engineer or Engineer-in-Training (CPI)
- Familiarity with industry guidelines such as ISPE, PDA, and ISO
Profile :
- Strong organizational and prioritization skills
- Excellent attention to detail and accuracy
- Autonomy, proactivity, and active listening skills
- Strong interpersonal and communication abilities
- Technical expertise and problem-solving mindset
Position Details
What We Offer
Position Highlights:
- Full-time (40 hours/week) – Permanent position
- Based in Montréal (Metro McGill – 630 Sherbrooke St. W, Montréal, QC, Canada)
- Travel zone within Montréal and surrounding areas
- Hybrid work model (office – client site – remote work up to 2 days per week)
- Competitive annual salary: $75,000 to $85,000 CAD, negotiable based on profile and experience
Comprehensive Benefits Package:
- Monthly professional allowance: $20 for cell phone expenses and 50% reimbursement of public transit pass
- Group insurance plan (drug, health, dental, and vision coverage) – 50% employer-paid
- Vacation: 3 weeks per year + 1 additional paid week (during the week of December 25)
- 5 paid sick days per year
- Access to diverse and stimulating projects in a collaborative work environment
- Modern downtown office, friendly team atmosphere, and monthly team events (5 to 7 socials)
Are you ready to take on this challenge and invest yourself in pharmaceuticals?
Submit your application to our recruitment team using the contact form on our website.
1
Application evaluation
2
HR interview
3
Technical interview